RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining radiation therapy with chemotherapy with may kill
more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy with vinorelbine and
paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the
OBJECTIVES: I. Assess the toxic effects of vinorelbine given on a weekly schedule combined
with standard whole pelvic radiation therapy. II. Determine the Maximum Tolerated Dose (MTD)
of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation
therapy. III. Access the toxic effects of paclitaxel given weekly in combination with the
regimen determined to be the MTD of vinorelbine. IV. Determine the MTD of paclitaxel given
weekly in combination with the regimen determined to be the MTD of vinorelbine.
OUTLINE: Part I: Vinorelbine IV bolus is administered over 8-10 minutes on day 1 prior to
radiation therapy. Whole pelvic radiation treatment is given on days 1-5 followed by 2 days
of rest. The treatment volume encompasses all suspected pelvic disease with a minimum of 1
cm margin. Cycles repeat weekly. Dose of vinorelbine is escalated in cohorts of at least 3
patients until maximum tolerated dose (MTD) is determined. Part II: Paclitaxel is infused
over 1 hour immediately following vinorelbine at the MTD, as determined in part I. Dose of
paclitaxel is escalated in cohorts of at least 3 patients until the MTD is determined. At
least 6 patients are treated at the MTD for both parts I and II of the study. Patients are
followed for late and chronic toxicities.
PROJECTED ACCRUAL: Projected accrual is 12 patients per year for approximately 3 years.
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced carcinoma of the
uterine cervix, vagina, or bladder or other pelvic malignancy for which whole pelvic
radiation therapy is planned Metastatic disease is permitted
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: CALGB 0-2 Hematopoietic: WBC at
least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal
limits Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No unstable angina or
myocardial infarction in previous 6 months Other: Not pregnant No significant concomitant
illness, uncontrolled infection, or cirrhosis
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior whole pelvic
radiation therapy Surgery: Not specified